Recordati Rare Diseases Inc. announces the publication of the long-term outcomes from the open-label extension period of the Phase III LINC 3 study of ISTURISA in The European Journal of Endocrinology.
| Long-term findings from the multicenter, international LINC 3 study demonstrated that treatment with ISTURISA® (osilodrostat) maintained cortisol normalization and was well tolerated in most patients with Cushing’s disease. LEBANON, N.J., Aug. 31, 2022 /PRNewswire/ -- Recordati Rare Diseases Inc. announces the publication of the long-term outcomes from the open-label extension period of the Phase III LINC 3 study of ISTURISA in The European Journal of Endocrinology.1 These data support the long-term utility of ISTURISA in the maintenance treatment of patients with Cushing’s disease and reinforce ISTURISA as an effective and well-tolerated oral therapy. ISTURISA is indicated in the United States for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.2 Cushing’s disease is a rare and debilitating condition of hypercortisolism that is caused by a pituitary adenoma.3 The Phase III LINC 3 study was the largest prospective trial of an adrenal steroidogenesis inhibitor to date. In total, 106 of the 113 patients who completed the 48-week core phase opted to continue receiving open-label ISTURISA during the extension phase, which ended after all patients completed ≥72 weeks of treatment or had discontinued the study. Median duration of exposure to ISTURISA from core study baseline to end of the extension was 130 weeks (range 1–245). Key findings published in the manuscript entitled ‘Long-term outcomes of osilodrostat in Cushing’s disease: LINC 3 study extension’ include:1
“Findings from our large trial, where patients with Cushing’s disease opted to continue treatment with osilodrostat during the extension, support osilodrostat as an effective, long-term treatment option for patients with this chronic disease,” said Maria Fleseriu, Professor of Medicine (Endocrinology) and Neurological Surgery and Director of the Pituitary Center at Oregon Health & Science University, Portland, OR, USA. “Importantly, as well as providing long-term normalization of cortisol, continued treatment with osilodrostat for over 72 weeks led to sustained improvements in clinical signs and physical manifestations of hypercortisolism and was generally well tolerated.” “These data support Isturisa as a viable long-term medical therapy option to maintain control of cortisol levels and signs and symptoms related to hypercortisolism in patients with Cushing’s disease, building on the core phase of the positive Phase III LINC 3 study, published in The Lancet Diabetes & Endocrinology in 2020,4” said Alberto M. Pedroncelli, Clinical Development & Medical Affairs Head, Global Endocrinology, Recordati AG. “Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition. On behalf of Recordati Rare Diseases, I would like to extend our thanks to all those who have contributed to LINC 3 and the LINC clinical development program.” The full publication can be found here. Important safety information for ISTURISA Indications and usage Warnings and precautions
Hypocortisolism can occur at any time during ISTURISA treatment. Evaluate patients for precipitating causes of hypocortisolism (infection, physical stress, etc). Monitor 24-hour urinary free cortisol, serum or plasma cortisol, and patient’s signs and symptoms periodically during ISTURISA treatment. Decrease or temporarily discontinue ISTURISA if urinary free cortisol levels fall below the target range, there is a rapid decrease in cortisol levels, and/or patients report symptoms of hypocortisolism. Stop ISTURISA and administer exogenous glucocorticoid replacement therapy if serum or plasma cortisol levels are below target range and patients have symptoms of adrenal insufficiency. After ISTURISA discontinuation, cortisol suppression may persist beyond the 4-hour half-life of ISTURISA. Please see section 5.1 of full Prescribing Information. Educate patients on the symptoms associated with hypocortisolism and advise them to contact a healthcare provider if they occur.
Adverse reactions
Drug interactions
Use in specific populations
Please refer to full Prescribing Information. About Cushing’s disease Cushing’s disease is a form of Cushing’s syndrome, in which chronically elevated cortisol levels is triggered by a pituitary adenoma secreting excess adrenocorticotropic hormone (ACTH).5 It is a rare, serious and difficult-to-treat disease that affects approximately one to two patients per million per year. Prolonged exposure to elevated cortisol levels is associated with considerable morbidity, mortality and impaired QoL as a result of complications and comorbidities.6 Normalization of cortisol levels is therefore a primary objective in the treatment of Cushing’s disease.7 About LINC 3 LINC 3 is a prospective, multicenter, 48-week trial with an 8-week, double-blind, randomized withdrawal phase, with optional extension phase to evaluate the safety and efficacy of ISTURISA in patients with Cushing’s disease. Assessment of mUFC response rate, change in mUFC, change in cardiovascular and metabolic-related parameters, change in patient-reported outcomes, changes in physical manifestations of hypercortisolism as well as general AEs and AEs of special interest were included as secondary endpoints. LINC 3 enrolled 137 patients with persistent or recurrent Cushing’s disease or those with de novo disease who were not candidates for surgery.4 About ISTURISA ISTURISA is a cortisol synthesis inhibitor that works by inhibiting 11-beta-hydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. ISTURISA is available as 1 mg, 5 mg and 10 mg film-coated tablets. Please see prescribing information for detailed recommendations for the use of this product.2 In March 2020, the FDA granted marketing authorization for ISTURISA in the United States. For more information visit www.isturisa.com. References
About Recordati Rare Diseases Inc. Recordati Rare Diseases Inc. is a biopharmaceutical company committed to providing often-overlooked orphan therapies to the underserved rare disease communities of the United States. Recordati Rare Diseases is a part of the Recordati Group, a public international specialty pharmaceutical company committed to the research and development of new specialties with a focus on treatments for rare diseases. Recordati Rare Diseases’ mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis and expand availability of treatments for people with rare diseases. The company’s U.S. corporate headquarters is located in Lebanon, NJ, with global headquarter offices located in Milan, Italy. For a full list of products, please click here: www.recordatirarediseases.com/us/products Recordati website: https://www.recordatirarediseases.com/us Company contact Media contact This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast as a result of a variety of reasons, most of which are beyond the Recordati group’s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the Recordati group’s activities and therefore, as such, it is not intended as medical scientific indication or recommendation, nor as advertising. PP-IST-US-0291 SOURCE Recordati Rare Diseases |
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